Hydrogen bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxy-N-methylbenzenesulphonamidato(2-)]cobaltate(1-)

Endpoint summary

Description of key information

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the skin sensitization potential of the test chemical Hydrogen bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxy-N-methylbenzenesulphonamidato(2-)] cobaltate(1-) (CAS No: 85959-75-7). The studies are as mentioned below:

 

The skin sensitization potential of test chemical was evaluated by authoritative database using Guinea pig maximization test. The test material in induction treatment was subjected onto the skin of guinea pig by intra-cutaneous injections of 0.1 ml of 0.1 % aqueous solution three times per day for 5 successive days followed by one intracutaneous challenge injection of the same solution after 4 weeks of induction treatment. No skin allergic reactions were observed. Hence, the test material was considered to be not skin sensitizing.

 

The above result was further supported by another skin sensitization study reported by same authoritative database for another read across chemical. In this study, the skin sensitization potential of test chemical was assessed in a 16 year period study. During the entire study, the cosmetic use of test chemical did cause a single case of contact allergy in humans within the 16 year period. Hence the test chemical was considered to be not sensitizing to the human skin.

 

Based on the above summarized studies for target chemical Hydrogen bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxy-N-methylbenzenesulphonamidato(2-)] cobaltate(1-) (CAS No: 85959-75-7) and its structurally and functionally similar read across substances,it can be concluded that the testchemical is unable to cause skin sensitization and considered as non-skin sensitizer. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data for the target chemical is summarized based on the structurally and functionally similar read across chemicals

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

WoE report is based on 2 skin sensitization studies as- WoE-2 and WoE-3.
Skin sensitization test was conducted on guinea pigs and humans to determine the potential of skin sensitization caused by the chemical.

GLP compliance:

not specified

Type of study:

other: 1.guinea pig maximisation test 2.Not specified

Justification for non-LLNA method:

not specified

Specific details on test material used for the study:

Name: Hydrogen bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxy-N-methylbenzenesulphonamidato(2-)] cobaltate(1-)
Molecular Formula: C34H28Cl2CoN10O8-S2.H
Molecular Weight: 899.6361 g/mole
InChI:1S/C17H16ClN5O4S.C17H15ClN5O4S.Co/c2*1-10-16(17(25)23(22-10)12-5-3-4-11(18)8-12)21-20-14-9-13(6-7-15(14)24)28(26,27)19-2;/h3-9,19,24-25H,1-2H3;3-9,16H,1-2H3,(H,21,24);/q;-1;+3/p-2/b21-20+;;

Species:

other: 1.guinea pig 2.human

Strain:

other: 1. Not specified 2.Not applicable

Details on test animals and environmental conditions:

No data available

Route:

intradermal

Vehicle:

water

Concentration / amount:

0.1 ml of 0.1 % aqueous solution

Day(s)/duration:

5 days

Adequacy of induction:

other: WoE-2

Route:

other: No data available

Adequacy of induction:

other: WoE-3

No.:

#1

Route:

intradermal

Vehicle:

water

Concentration / amount:

0.1 ml of 0.1 % aqueous solution

Day(s)/duration:

Not specified

Adequacy of challenge:

other: WoE-2

Route:

other: No data available

Adequacy of challenge:

other: WoE-3

No. of animals per dose:

Not specified

Details on study design:

1. A. INDUCTION EXPOSURE
- No. of exposures: 3 times/ day for 5 successive days
- Exposure period: not speccified
- Test groups: not specified
- Control group: not specified
- Site: not specified
- Frequency of applications: 3 times a day
- Duration: not specified
- Concentrations: 0.1 ml of 0.1 % aqueous solution


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: not specified
- Exposure period: not specified
- Test groups: not specified
- Control group: not specified
- Site: not specified
- Concentrations: 0.1 ml of 0.1 % aqueous solution
- Evaluation (hr after challenge): not specified

OTHER: challenge treatment was provided 4 weeks after the induction

2.Not specified

Challenge controls:

not specified

Positive control substance(s):

not specified

Reading:

1st reading

Group:

test chemical

Dose level:

0.1 ml of 0.1 % aqueous solution

Clinical observations:

No skin allergic reactions were observed.

Remarks on result:

no indication of skin sensitisation

Reading:

1st reading

Group:

test chemical

Dose level:

No data available

No. with + reactions:

0

Clinical observations:

A 16-years period of use in cosmetics not a single case of allergy in humans.

Remarks on result:

no indication of skin sensitisation

Cellular proliferation data / Observations:

1.No skin allergic reactions were observed.
2.A 16-years period of use in cosmetics not a single case of allergy in humans.

Interpretation of results:

other: Not sensitizing

Conclusions:

The test material Hydrogen bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxy-N-methylbenzenesulphonamidato(2-)] cobaltate(1-) (CAS No: 85959-75-7) was considered to be not sensitizing to the skin of guinea pigs and humans.

Executive summary:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the skin sensitization potential of the test chemical Hydrogen bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxy-N-methylbenzenesulphonamidato(2-)] cobaltate(1-) (CAS No: 85959-75-7). The studies are as mentioned below:

 

The skin sensitization potential of test chemical was evaluated by authoritative database using Guinea pig maximization test. The test material in induction treatment was subjected onto the skin of guinea pig by intra-cutaneous injections of 0.1 ml of 0.1 % aqueous solution three times per day for 5 successive days followed by one intracutaneous challenge injection of the same solution after 4 weeks of induction treatment. No skin allergic reactions were observed. Hence, the test material was considered to be not skin sensitizing.

 

The above result was further supported by another skin sensitization study reported by same authoritative database for another read across chemical. In this study, the skin sensitization potential of test chemical was assessed in a 16 year period study. During the entire study, the cosmetic use of test chemical did cause a single case of contact allergy in humans within the 16 year period. Hence the test chemical was considered to be not sensitizing to the human skin.

 

Based on the above summarized studies for target chemical Hydrogen bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxy-N-methylbenzenesulphonamidato(2-)] cobaltate(1-) (CAS No: 85959-75-7) and its structurally and functionally similar read across substances,it can be concluded that the testchemical is unable to cause skin sensitization and considered as non-skin sensitizer. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the skin sensitization potential of the test chemical Hydrogen bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxy-N-methylbenzenesulphonamidato(2-)] cobaltate(1-) (CAS No: 85959-75-7). The studies are as mentioned below:

 

The skin sensitization potential of test chemical was evaluated by authoritative database using Guinea pig maximization test. The test material in induction treatment was subjected onto the skin of guinea pig by intra-cutaneous injections of 0.1 ml of 0.1 % aqueous solution three times per day for 5 successive days followed by one intracutaneous challenge injection of the same solution after 4 weeks of induction treatment. No skin allergic reactions were observed. Hence, the test material was considered to be not skin sensitizing.

 

The above result was further supported by another skin sensitization study reported by same authoritative database for another read across chemical. In this study, the skin sensitization potential of test chemical was assessed in a 16 year period study. During the entire study, the cosmetic use of test chemical did cause a single case of contact allergy in humans within the 16 year period. Hence the test chemical was considered to be not sensitizing to the human skin.

 

Based on the above summarized studies for target chemical Hydrogen bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxy-N-methylbenzenesulphonamidato(2-)] cobaltate(1-) (CAS No: 85959-75-7) and its structurally and functionally similar read across substances,it can be concluded that the testchemical is unable to cause skin sensitization and considered as non-skin sensitizer. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

The skin sensitization potential of test substance Hydrogen bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxy-N-methylbenzenesulphonamidato(2-)] cobaltate(1-) (CAS No: 85959-75-7) and its structurally and functionally similar read across substanceswere observed in various studies. From the results obtained from these studies it is concluded that the chemical Hydrogen bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxy-N-methylbenzenesulphonamidato(2-)] cobaltate(1-) (CAS No: 85959-75-7) is not likely to cause skin sensitization and hence can be classified as non-skin sensitizer.